BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 17835719 · Received September 28, 2023

    Report

    Report Number
    3013756811-2023-137957
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 28, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AVOID EXPOSURE OF YOUR PUMP TO TEMPERATURES BELOW 40°F (5°C) OR ABOVE 99°F (37°C). INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. INSULIN THAT HAS BEEN EXPOSED TO CONDITIONS OUTSIDE OF THE MANUFACTURER¿S RECOMMENDED RANGES CAN AFFECT THE SAFETY AND PERFORMANCE OF THE PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY THE CUSTOMER IS USING COLD INSULIN. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT USING COLD IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 200-445 MG/DL, WITH HIGH KETONES. REPORTEDLY, THE CUSTOMER'S GIRLFRIEND ASSISTED CUSTOMER WITH INSERTING MANUAL INSULIN INJECTIONS TO ADDRESS ELEVATED (BG) LEVEL. ULTIMATELY, THE CUSTOMER REVERTED TO AN ALTERNATE FORM OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037132 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male INFUSION SET: AUTOSOFT XCINSULIN TYPE: HUMALOG